Five Prime Therapeutics, Inc. is a biopharmaceutical company focused on discovering and developing transformative protein-based medicines for patients with serious unmet medical needs. The company has an emerging portfolio of innovative products for inflammation and cancer including:
• FP-1039 – An FGF ligand trap in Phase Ib for solid tumors
• FPA008 – a monoclonal antibody in Phase I targeting CSF1R for inflammatory diseases
• FPA144 – a monoclonal antibody targeting FGFR2b for selected gastric cancers
• Potential immune checkpoint regulators for cancer immunotherapy
FivePrime’s discovery platforms can rapidly interrogate the entire extracellular proteome in medically relevant in vitro and in vivo models leading to novel targets and drug leads. Our technology has been validated by our growing pipeline and through multiple partnerships with pharmaceutical companies including Johnson & Johnson, Pfizer, GlaxoSmithKline, and UCB across a range of therapeutic indications. FivePrime is committed to innovation and outstanding science, values which are reflected in our people and our products.
Reporting to the Chief Medical Officer, the Clinical Pharmacokinetic (PK) Scientist will have overall responsibility for conducting PK assessments of FPRX molecules in clinical phase studies that involve PK sampling, assessment of metabolites, pharmacodynamics (PD) biomarkers and drug: drug interactions; modeling PKPD + PopPK data; and working collaboratively with the cross-functional clinical development teams to identify the maximally tolerated/recommended Phase 2 dose and schedule of a molecule in a given program. Additionally, the candidate will collaborate on the preclinical PK assessment of preclinical compounds, working closely with the preclinical scientists and pharmacologists. The candidate will work within the project team structure, sitting on core project teams to guide strategy, and working within relevant sub-teams to ensure tactical alignment and execution.
The optimal candidate will demonstrate leadership qualities with extensive knowledge and experience in developing Phase 1 protocols, analyzing pharmacokinetics and drug metabolism data, managing vendors, and advancing pharmaceutical large molecules (biologics) through preclinical, clinical stages, BLA/NDA submissions, and Advisory/Scientific Committee Meetings. The candidate will have authored relevant sections of regulatory submissions for INDs, CTAs and global filings and, ideally, will have an established a track record of publishing articles and abstracts in professional journals.
• Participate in study design, vendor selection, study execution, interpretation and report writing for all clinical activities that pertain to PK assessment of FivePrime compounds
• Ensure that high-quality science knowledge/insight drives the customized PK plan for each compound
• Ensure timely execution of defined clinical PK development plans, with appropriate quality controls and high quality written report production
• Reviewing/editing and sometimes writing relevant sections of regulatory submissions – IND, IMPD, CTA, CSR/NDA etc
• Maintain up-to-date knowledge of evolving regulatory requirements and climate in US and Europe (Asia knowledge a plus)
• Lead writing of scientific publications on relevant topics – abstracts, posters, oral presentations and manuscripts
• Effectively integrate pre-clinical and clinical PK development with Translational Research
• Work collaboratively with colleagues in both discovery and development team settings: manage resources efficiently to identify and address key PK issues, risk management, in vivo preclinical PK data and human PK simulation
• Work collaboratively with nonclinical PK and translational scientists on PK aspects of nonclinical studies
• Be responsible for management of non-GLP and GLP bioanalytical and PK CRO contracts where appropriate
• Be an active participant in the due diligence process delivering sound scientific analysis augmented by industrial experiences and attention to details
BioSpace.com - 8 months ago